Pioglitazone Back on Market in India

August 06, 2013

As expected, the Indian government has revoked its suspension of the type 2 diabetes drug pioglitazone. However, it has stipulated that the agent should not be used as first-line treatment for diabetes and that it should carry a boxed warning relating to bladder cancer.

The decision to suspend the manufacture, sale, and distribution of pioglitazone in India, citing concerns over adverse effects, particularly bladder cancer, came out of the blue in June and was widely criticized by doctors and others there. In mid-July, however, a meeting of the drug technical advisory board (DTAB) recommended that pioglitazone be put back on the market.

Now, the Ministry of Health and Family Welfare has announced that all formulations containing pioglitazone for human use are allowed to be manufactured, sold, and distributed once again, albeit with warnings on the package insert.

Beilib D.G. Shah, secretary general of the Indian Pharmaceutical Alliance (IPA), whose 19 research-based national pharmaceutical company members were infuriated by the decision to ban pioglitazone, told Medscape Medical News: "The IPA is relieved with the corrective action to ensure continued access to a safe and affordable treatment for diabetic patients."

However, in future, "the IPA expects that…the drug regulator will follow a predictable, unbiased process based on evidence to suspend or ban a medicine in the country," he added.

Cautions on Bladder Cancer History, Risk Factors, and Age

The new warnings, which must be listed on pioglitazone formulations in India, will state that patients with active bladder cancer or with a history of bladder cancer and those with uninvestigated hematuria should not receive pioglitazone.

And before starting the drug, individuals should be assessed for known risk factors for bladder cancer, including age, smoking history, exposure to occupational or chemotherapy agents, or previous irradiation of the pelvic region.

Prescribers should also review the use of the agent after 3 to 6 months to ensure that only patients who are deriving benefit from it continue to be treated. "Pioglitazone should be stopped in patients who do not respond adequately to treatment," the government notification states.

There is also special advice for the use of pioglitazone in elderly patients, which "should be considered carefully before and during treatment because the risk of bladder cancer increases with age." Elderly patients should start on the lowest possible dose "and be regularly monitored because of the risks of bladder cancer and heart failure associated with pioglitazone."

Delay Before Pioglitazone Is Available Again

Reports in the Indian media have largely welcomed the reintroduction of pioglitazone but have pointed out that it will be a few weeks before supplies are back to normal.

"As per the notification, the drug can be sold only if it carries the warning literature," Damji Pallan, from Retail Drug and Chemist Association (RDCA), Mumbai, told the Hindustan Times . "The stock we have does not have the necessary warnings, so we are waiting for manufacturing companies to take back the stock and repackage it."

One diabetologist, who requested anonymity, told the same newspaper: "With warnings on boxes, initiating new patients on this drug will be difficult. But those patients who have been on pioglitazone are waiting to get back on the drug."

Another, Rajiv Kovil, MD, from Dr Kovil's Diabetes Care Centre, Mumbai, said, "As a result of the ban, many patients who were on pioglitazone have switched to other drugs or insulin. They will have to continue with the alternatives…until the drug with the prescribed warning arrives."

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